Posted by Michael Wonder on 03 Jul 2023
Innovent and IASO Bio announce the NMPA approval of Fucaso, the first fully human BCMA CAR-T therapy, for the treatment of relapsed or refractory multiple myeloma
3 July 2023 - Innovent Biologics and IASO Biotechnology announce that China's National Medical Products Administration has approved the new drug application for Fucaso (equecabtagene autoleucel), the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The new drug application approval was based on the results from the FUMANBA-1 clinical study, a multi-center Phase I/II registrational clinical trial conducted in China to evaluate the efficacy of equecabtagene autoleucel in patients with relapsed or refractory multiple myeloma.
